Clean Room Production Coordinator - Packaging - Night Shift

 Requisition ID:                       63268                          Title: Clean Room Production Coordinator - Packaging - Night Shift Division: Arthrex Manufacturing Inc (US02) Location: AMISC-A (US28)

 

 

 

 

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex Manufacturing Inc. is actively searching for a Production Coordinator in our Packaging Clean Room supporting Night Shift (Monday through Thursday, 7:30 pm to 6 am) at the Pendleton, SC location. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

 

Essential Duties and Responsibilities:

• Perform daily, monthly and semi-annual terminal cleaning activities in the clean room.
• Responsible for accessing and following packaging instructions and work instructions from PLM and Document management systems based on product structure requirements.
• Perform manual and fixture assisted device assembly and packaging on medical device components, kits, convenience packs and/or any clean room specific device assembly as assigned.
• Responsible for DHR and ERP accuracy and completion.
• Apply labels onto pouches and blisters including label reconciliation.
• Perform supplemental label application, blister loading, pouch and blister sealing and visual inspection.
• Operate clean room specific equipment, automated robotic assembly equipment as needed.
• Alert of any maintenance or repair issues of any equipment or tools.
• Perform changeovers and line setups.
• Perform area clearance and maintain line separation while running work orders.
• Responsible for managing and segregating scrap.
• Ensure correct and complete assembly of device.
• Performs AQL inspection in accordance with stated inspection criteria.
• Manages activities involving QC Hold and/or MRB related issues.
• Assist in product and packaging validation tests when necessary.
• Adhere to all Quality System Requirements.
• Promotes a safe work environment including the use of PPE when required.  Communicates issues to management that could result in process delays and/or safety issues.
• Train all employees on device assembly and packaging techniques.

 

Education/Experience:

• High School Diploma or equivalent required.  Some college desired.
• At least 1 year of manufacturing experience related to manufacturing, assembly and/or packaging including operation of mechanized equipment.
• Successful completion of the Leadership Development Program (Leadership) required. Or, enrolled in the Leadership Development Program within 6 months of hire with a successful completion of the program.
• Lean Manufacturing experience is preferred.
• Train-the-Trainer Certification, or equivalent required.

 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Proficiency on MS Office required.
• A thorough knowledge of packaging processes, product assembly, visual inspection, packaging, and labeling requirements.
• Perform tasks by reading, understanding and following work instructions/documents provided.
• Understanding of Work Instructions, Routers, BOM’s, and DHR’s required.
• Ability to interpret/comprehend blueprints, written specifications, technical documents and protocols, rework addendums, data forms, and packaging and work instructions.
• Basic knowledge of raw materials, inventory, production processes, barcode scanning and labeling controls, inspection methods, equipment, and other techniques for the effective manufacturing a